BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 12972426 · Received December 9, 2021

    Report

    Report Number
    1119779-2021-01936
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 12, 2021
    Report Date
    January 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM KIT (REF 44500301) LOT 1252944 WAS PERFORMED BY THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD SARS-COV-2 REAGENTS INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED DISCREPANT SAMPLES WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (44500301), COMPARED TO THE ARIES® SARS-COV-2 ASSAY. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO DATA WAS PROVIDED FOR THE INVESTIGATION. CUSTOMER MENTIONED SIX DISCREPANT RESULTS BETWEEN THE BD SARS-COV-2 REAGENTS KIT AND THEIR VERIFICATION METHOD (ARIES® SARS-COV-2 ASSAY).IT MUST BE NOTED THAT THIS OTHER ASSAY DOES NOT DETECT THE SAME GENE TARGETS AS THE BD SARS-COV-2 REAGENTS KIT. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. WITHOUT ANY DATA, NO ANALYSIS WAS POSSIBLE, AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD WAS UNABLE TO CONFIRM THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD SARS-COV-2 REAGENTS FOR BD MAX¿ PRODUCT LOT 1252944. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). H

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, IT PRODUCED 6 FALSE POSITIVE RESULTS. CONFIRMATORY TESTING WAS PERFORMED ON ANOTHER PCR ASSAY WITH RESULTS RETURNING AS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD FOUR PATIENT SAMPLES (1 RUN) THAT WERE COV-2 POSITIVE ON THE BD MAX CATALOG# 44500301, LOT# 1252944, BUT WERE NEGATIVE ON ANOTHER PCR ASSAY". "THE FOUR PATIENT SAMPLES WERE RE-TESTED ON THE LUMINEX PCR ASSAY AND THE RESULTS WERE NEGATIVE." "HE CONFIRMS THERE HAS BEEN A TOTAL OF 6 DISCREPANT RESULTS IN THE PAST TWO WEEKS, WITH ONE OCCURRING THIS WEEK, WITH THE SAME LOT# OF COV-2 REAGENTS. ENVIRONMENTAL SAMPLES WERE RUN ON 11/23 AND WERE NEGATIVE FOR CONTAMINATION (UNRESOLVED RESULTS) BUT ONLY TWO SITES WERE SWABBED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, IT PRODUCED 6 FALSE POSITIVE RESULTS. CONFIRMATORY TESTING WAS PERFORMED ON ANOTHER PCR ASSAY WITH RESULTS RETURNING AS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD FOUR PATIENT SAMPLES (1 RUN) THAT WERE COV-2 POSITIVE ON THE BD MAX CATALOG# 44500301, LOT# 1252944, BUT WERE NEGATIVE ON ANOTHER PCR ASSAY" "THE FOUR PATIENT SAMPLES WERE RE-TESTED ON THE LUMINEX PCR ASSAY AND THE RESULTS WERE NEGATIVE." "HE CONFIRMS THERE HAS BEEN A TOTAL OF 6 DISCREPANT RESULTS IN THE PAST TWO WEEKS, WITH ONE OCCURRING THIS WEEK, WITH THE SAME LOT# OF COV-2 REAGENTS. ENVIRONMENTAL SAMPLES WERE RUN ON 11/23 AND WERE NEGATIVE FOR CONTAMINATION (UNRESOLVED RESULTS) BUT ONLY TWO SITES WERE SWABBED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871126 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1252944

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown